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NCT01210001 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 499
- Enrollment target
NCT01210001: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01210001 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 499 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01210001, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 499 participants
- Enrollment target
Study Summary
This study will investigate the efficacy and safety of BI 10773 in type 2 diabetic patients in order to provide these data for approval for BI 10773 by regulatory authorities as an antidiabetic agent as add-on therapy to pioglitazone alone or in combination with metformin.
Primary Outcome
Change From Baseline in HbA1c after 24 weeks. Note that adjusted means are provided.
Interventions
- DRUG Placebo
- DRUG BI 10773
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 499 participants |
| Start Date | 2010-09 |
| Phase | Phase 3 |
What the finished NCT01210001 record still lists
NCT01210001 is an interventional study that assigns participants to a tested intervention. The registered 499 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01210001 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01210001 about?
NCT01210001 is a clinical study titled "Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin". This study will investigate the efficacy and safety of BI 10773 in type 2 diabetic patients in order to provide these data for approval for BI 10773 by regulatory authorities as an antidiabetic agent as add-on therapy to pioglitazone alone or in combination with metformin.
What is the current status of trial NCT01210001?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 499 participants. The study started on 2010-09.
What interventions are being tested in trial NCT01210001?
The interventions under investigation include: Placebo (DRUG), BI 10773 (DRUG).
Who is sponsoring clinical trial NCT01210001?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01210001's enrollment target sits among peer trials
499 775th of 2000 higher than 1,226 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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